Quality & Safety of Generic Drugs in the World Market World Bank Conference “Good Intentions – Bad Drugs” March 10, 2005 Washington, D.C. Christine Simmon VP, Public Affairs & Development Generic Pharmaceutical Association

GPhA: Who We Are The organization representing the entire generic drug industry – Single, unified voice to FDA, legislators, public – >140 members Manufacturers, API suppliers, CROs, others – Members produce >98% of generic drugs sold in the U.S.

Counterfeit & Substandard Products: A Growth Industry FDA counterfeiting investigations have increased 400% over the last several years. Global problem – WHO estimates counterfeits comprise 5-8% of world market – WHO survey found 60% of counterfeit medicine cases occurred in poor countries; 40% in industrialized countries. Factors Driving Counterfeiting: – Economic Factors – Weaknesses in the drug distribution system – Importation of unregulated medicines – Internet pharmacies

Quality is Paramount Substandard Medicines Concern Brand & Generic Sectors – Mislabeling – Fraudulent packaging – Subpar ingredients Adverse Health Consequences – Emerging resistance for infectious diseases – Inadequate treatment – Death Adverse Economic Consequences – WHO estimates sales of counterfeit medicines at US $32 billion annually

Setting Standards FDA USP Competent Regulatory Authorities/Counterparts

Systemic Problem, Systemic Solutions Governmental approaches – Regulation – Enforcement – Global Information Exchange – Education Implicates all parts of the drug distribution chain – API Suppliers – Manufacturers – Wholesalers – Distributors

GPhA: Partnering In Quality Assurance Worldwide FDA RFID & Other Measures USP International Monograph WHO’s Counterfeiting & Drug Quality Working Group/IGPA U.S. Department of Commerce CUMVIVIUM

Thank You! Christine Simmon Vice President, Public Affairs & Development Generic Pharmaceutical Association ; (fax) 2300 Clarendon Blvd., Ste. 400 Arlington, VA 22201